Colorectal Surgery Unit, Department of General Surgery, Mansoura University Hospitals, Mansoura University, Dakahliya, Egypt.
Dis Colon Rectum. 2019 Aug;62(8):980-987. doi: 10.1097/DCR.0000000000001416.
Complex anal fistula is one of the challenging anorectal conditions. Several treatments have been proposed for complex anal fistula, yet none proved to be ideal.
This randomized trial aimed to assess the efficacy of external anal sphincter-sparing seton in comparison with the conventional drainage seton in the treatment of complex anal fistula.
This was a prospective, randomized, single-blind controlled study.
The study was conducted at the Colorectal Surgery Unit of Mansoura University Hospitals.
Adult patients of both sexes with complex anal fistula were recruited and evaluated with MRI before surgery.
Patients were randomly divided into 2 groups; group 1 was treated with conventional drainage seton and group 2 was treated with external anal sphincter-sparing seton using a rerouting technique.
The duration of healing, incidence of recurrence or persistence, postoperative pain, and complications including fecal incontinence were measured.
Sixty patients (56 men) with a mean age of 43 years were included. Mean operation time in group 1 was significantly shorter than group 2 (29.8 ± 4.3 vs 43.8 ± 4.5 min; p < 0.0001). The mean pain score at 24 hours in group 1 was 8.1 ± 1.6 versus 5.3 ± 1.3 in group 2 (p < 0.0001). Five patients (17%) in group 1 experienced complications versus 2 (7%) in group 2. All of the patients in group 1 required a second-stage fistulotomy versus 2 patients (7%) in group 2 (p < 0.0001). Time to complete healing in group 1 was significantly (p < 0.0001) longer than group 2 (103 ± 47 vs 46 ± 18 d). Four patients (13%) in group 1 and 1 patient (3%) in group 2 experienced persistence or recurrence of anal fistula (p = 0.35).
This was a single-center study with relatively small numbers in each group.
Patients treated with external anal sphincter-sparing seton after rerouting of the fistula tract achieved quicker healing and less postoperative pain than those with conventional drainage seton. Postoperative complication and recurrence rates were comparable in both groups. See Video Abstract at http://links.lww.com/DCR/A963.
clinicaltrials.gov identifier: NCT03636997 (https://clinicaltrials.gov/ct2/show/NCT03636997).
复杂性肛痿是一种具有挑战性的肛肠疾病。针对复杂性肛痿，已经提出了几种治疗方法，但没有一种被证明是理想的。
本随机试验旨在评估保留外括约肌的肛痿切开挂线术与传统引流挂线术治疗复杂性肛痿的疗效。
这是一项前瞻性、随机、单盲对照研究。
该研究在曼苏拉大学医院的肛肠外科病房进行。
招募了成年男女患者，所有患者均接受 MRI 术前评估。
患者随机分为两组；一组采用传统引流挂线术治疗，另一组采用外括约肌保留的肛痿切开挂线术（采用改道技术）。
愈合时间、复发或持续存在的发生率、术后疼痛以及包括粪便失禁在内的并发症。
共纳入 60 名（56 名男性）平均年龄为 43 岁的患者。第 1 组的手术时间明显短于第 2 组（29.8±4.3 比 43.8±4.5 分钟；p<0.0001）。第 1 组术后 24 小时疼痛评分平均为 8.1±1.6，而第 2 组为 5.3±1.3（p<0.0001）。第 1 组 5 名（17%）患者发生并发症，而第 2 组 2 名（7%）患者发生并发症（p<0.0001）。第 1 组所有患者均需进行二期痿管切开术，而第 2 组仅 2 名（7%）患者需进行二期痿管切开术（p<0.0001）。第 1 组的完全愈合时间明显长于第 2 组（103±47 比 46±18 天；p<0.0001）。第 1 组 4 名（13%）患者和第 2 组 1 名（3%）患者出现肛痿持续或复发（p=0.35）。
这是一项单中心研究，每组患者数量相对较少。
与传统引流挂线术相比，经瘘管改道的外括约肌保留的肛痿切开挂线术治疗患者愈合更快，术后疼痛更少。两组术后并发症和复发率相当。详见视频摘要，网址：http://links.lww.com/DCR/A963。
clinicaltrials.gov 标识符：NCT03636997（https://clinicaltrials.gov/ct2/show/NCT03636997）。
